The release of the report on medical device registration in 2019: the reform and innovation of device audit have become increasingly active
Source: China medical journal by hu fang 01:56, March 18, 2020
On March 17, the national medical products administration released a report on the registration of medical devices in 2019 (hereinafter referred to as the report).
The report comprehensively sorts out and analyzes the registration of medical devices in China in 2019.
In 2019, the state food and drug administration (sfda) continued to deepen the reform of the review and approval system for medical devices, actively promoted scientific research and smart regulation, and achieved fruitful results in international exchanges, according to the report.
Driven by the policy, China's medical device r&d and innovation will be active in 2019, with the quality of r&d constantly improving, and the Chinese market will be favored by more multinational enterprises.
Steady progress was made in the reform of device audit
To revise the regulations on the supervision and administration of medical devices, and to formulate and revise the supporting regulations and normative documents simultaneously;
The regulations on the supervision and administration of customized medical devices (trial) was issued to provide policy support for further encouraging the innovation and research and development of customized medical devices.
We issued 50 guidelines for the technical review of medical devices, including the guidelines for the conditional approval of medical devices to market, and unified the review scale...
In 2019, China's medical device regulatory system will be further improved, and the reform of the review and approval system for medical devices is also making steady progress.
According to the report, in order to continuously deepen the reform of the review and approval system for medical devices in 2019, the state food and drug administration played a combination of functions. It issued the notice on adjusting the approval procedures for clinical trials of medical devices, further improved the approval procedures for clinical trials, and changed the "express" license to "implied" license.
Clinical trials to continue expanding from the directory of medical equipment, new 148 item of medical equipment products and 23 products from clinical trials, in vitro diagnostic reagent for 48 medical equipment products and four product name and description in vitro diagnostic reagent was revised - by the end of 2019, medical apparatus and instruments in clinical trials from directory contains 1003 entries, in vitro diagnostic reagents directory contains 416, total 1419 items;
Expand the registrant system of medical equipment, push the pilot medical apparatus and instruments registrant system to Beijing, jiangsu, zhejiang and other 21 provinces (autonomous regions and municipalities), 2019, the year a total of 22 enterprise 93 products in accordance with the registrant pilot system, including the provinces commissioned production and class iii medical devices by registrant system commissioned production etc.
Experts believe that the pilot expansion of medical device registrant will not only further release the system dividend of medical device registrant, encourage the innovation of medical device, but also provide important support for the comprehensive implementation of the medical device registrant system.
Continue to do a good job in the approval of innovative medical devices.
According to the data, a total of 36 innovative products and 12 priority products entered the "green channel" in 2019, and 10 priority products, including 19 innovative medical devices such as positron emission tomography and magnetic resonance imaging systems and hollow fiber membrane hemodialysis filters, were approved for market.
"These products have been approved to market, promoting the innovative development of the medical device industry and meeting the people's demand for using high-level medical devices."
The state food and drug administration instrument registration department said the relevant personage.
In addition, in 2019, the state food and drug administration will continue to consolidate the basic work of medical devices, further improve the standard system of medical devices, and continuously improve the classification and naming work.
By the end of 2019, there were 1,671 standards in effect for medical devices, including 220 national standards and 1,451 industrial standards. The consistency between China's standards and international standards reached more than 90.4 percent.
Smart regulation has yielded initial results
Smart regulation and regulatory science are also in full swing in 2019, according to the report.
In June 2019, the state food and drug administration launched the electronic declaration for medical device registration, and established the electronic declaration information system (eRPS) for medical device registration and online application.
By the end of 2019, 7,512 registration applications had been submitted online.
In addition, the sfda also implemented the unique identification of medical devices in 2019: issued the system rules for unique identification of medical devices and related standards, completed the construction of the first phase of the unique identification database of medical devices, and endowed the products with "electronic identity CARDS";
Strengthen source code assignment, explore the whole chain linkage from source production to clinical use;
Jointly issued the work plan for the pilot project of the unique identification system for medical devices with the national health commission, and jointly carried out the pilot project;
The first batch of notices concerning the unique identification of medical devices were issued to clarify the scope of varieties, schedule and work requirements and promote the orderly implementation of the unique identification of medical devices step by step.
Wisdom in promoting the regulation at the same time, the state food and drug administration has also launched China's drug regulatory science plan of action, the first to start the project evaluation research, including YaoXie combination product technology in artificial intelligence medical equipment safety evaluation of the effectiveness, medical device regulatory science research of new materials, real world data used in the study of medical instrument clinical evaluation methodology.
In 2019, according to the research project, the state food and drug administration set up national regulatory scientific research bases in sichuan university and south China university of technology to promote scientific research in the supervision of medical devices.
According to the report, in combination with the project of the scientific action plan for regulation, the sfda will also actively promote the trial application of real-world clinical data in 2019, formulate pilot programs, determine pilot products and formulate the technical guidelines for the use of real-world data for clinical evaluation of medical devices based on key regions.
While China's medical device regulation is becoming more scientific and law-based, it is also contributing more Chinese wisdom to the global medical device regulation.
The report pointed out that in the international medical device regulatory BBS (IMDRF) 16th management committee meeting, our country led by the clinical evaluation of clinical evidence - key definitions and concept of the working party "clinical evaluation", "clinical research" three guide documents approved, this is the first time since China joined IMDRF organization led by China's drug regulators write guidelines;
Medical devices regulations to coordinate in the 24th Asia (AHWP) annual meeting, as AHWP vice chairman and two working group chairman, introduces new developments and regulatory system, China medical device registration management working group work discussion and regulatory coordination, give full play to the role in the regional medical equipment supervision, actively promote Asia law coordination.
Industrial development was further invigorated
According to the report, China's medical device industry remained active in 2019 under the promotion of various active policies, and the r&d of the third type of medical device in China grew rapidly. The Chinese market has also attracted more and more attention from international large medical device companies.
According to the report, the total number of applications received and registrations approved by the sfda in 2019 was much higher than that in 2018.
Specifically speaking:
In 2019, the state food and drug administration accepted 9,104 applications for the first registration of medical devices, renewal of registration and change of licensing items according to its functions and duties, an increase of 37.8 percent compared with 2018.
A total of 3,511 applications for category iii medical devices were accepted in China, an increase of 47.4% compared with 2018.
Applications for the registration of imported medical devices were accepted in 5,593 cases, an increase of 41.8 percent compared with 2018, among which 2,540 were registered for the import of category iii medical devices, an increase of 20.9 percent compared with 2018.
In 2019, the state food and drug administration approved 8,471 medical devices for initial registration, renewal or change of registration, an increase of 53.2 percent over 2018.
Among them, 3,179 domestic registrations of category iii medical devices were approved, an increase of 86.0% from 2018.
5292 medical devices were approved for import, an increase of 38.6 percent over 2018, of which 2,538 were registered for import of category iii medical devices, an increase of 38.9 percent over 2018.
According to the report, 1,726 first-time registrations of medical devices were approved by the state food and drug administration in 2019.
Two sets of data are noteworthy:
The top five medical devices registered in China are: passive implant devices, infusion devices, nursing and protective devices, neurological and cardiovascular surgical devices, medical imaging devices and active surgical devices.
The top five imported medical devices registered are: medical imaging devices, dental devices, passive implant devices, clinical examination devices, nerve and cardiovascular surgical devices.
According to the registration of the third category of medical devices in China in 2019, the manufacturers of relevant registered products are mainly in the coastal provinces with relatively developed economy.
Among them, jiangsu, Beijing, guangdong, Shanghai and zhejiang are among the top five provinces in the number of first registrations of category iii medical devices, accounting for 69.1% of the first registrations of category iii medical devices in 2019, a slight increase compared with 2018.
In 2019, medical devices from the United States, Germany, Japan, the republic of Korea and Switzerland ranked among the top five countries in the number of first registrations of imported medical devices in China, accounting for 75.4% of the total number of first registrations of imported products in 2019, roughly the same as in 2018.
It is not difficult to see that the registration of the third type of medical devices in China gradually converges with the imported products, and the registration places of the products are relatively concentrated, which shows that in the field of high-end medical devices, the domestic market competition is becoming increasingly fierce, and the r&d capacity of the strong is always strong.
The copyright of this article belongs to the original, does not represent the position of this site.
We reprint this article for the purpose of disseminating more information.